Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1060M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MHW

Product Code Name

Dressing, Compression

Public Device Record Key

6e6200a8-9825-4339-af65-dd7947f72e50

Public Version Date

October 07, 2019

Public Version Number

2

DI Record Publish Date

November 08, 2018

Package DI Number

10818323021025

Quantity per Package

100

Contains DI Package

00818323021028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case